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The course you are looking at is not like any other e-Learning course you have ever taken. Watch this short video to learn why!

FDA Regulation Reversion: Laboratory Developed Tests (LDTs) Compliance

$19.99

Stay current with FDA requirements for laboratory developed tests (LDTs) following the vacatur of the May 2024 amendment to 21 CFR 809.3(a). This course details the regulatory reversion, compliance expectations, and significant cost savings resulting from the court’s decision. Learn exactly what has changed, what is required for ongoing compliance, and the impact for your organization. Ensure your policies and procedures align with the pre-May 2024 framework and be prepared for enforcement from September 19, 2025 onward.

In this course you will learn the following:
* Understand the regulatory background and the court decision leading to the vacatur.
* Identify the specific changes to 21 CFR 809.3(a) and related statutory citations.
* Recognize the compliance requirements and effective date of the reverted regulation.
* Assess the economic implications and cost savings resulting from the vacatur.
* Understand the consequences of non-compliance with the reverted regulation.

NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year.  At the end of the one year term, the course will be set to “inactive”. 

SKU: FR-25-1539-1 Categories: , , , , Tags: , Course: FDA Regulation Reversion: Laboratory Developed Tests (LDTs) Compliance
SKU: FR-25-1539-1 Categories: , , , , Tags: , Course: FDA Regulation Reversion: Laboratory Developed Tests (LDTs) Compliance

Why This Course is Important
Without this course, you risk non-compliance with the reverted FDA regulations for LDTs, leading to potential enforcement actions, penalties, or operational disruptions. You could also miss out on understanding substantial cost savings and the necessary steps to align with the current regulatory landscape.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur.

Key regulatory references include:

Course SKU
FR-25-1539-1

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